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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521307-43-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| ANRS, Emerging Infectious Diseases | OTHER_GOV |
| Région La Réunion | UNKNOWN |
| ARS La Réunion | UNKNOWN |
| Direction Générale de l'Offre de Soins |
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Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated group | Experimental | Patients who will be vaccinated with the IXCHIQ vaccine |
|
| Non-vaccinated group | No Intervention | Patient who will not be vaccinated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IXCHIQ | Biological | Group of vaccinated arm will be with the IXCHIQ vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the vaccine effectiveness at 6 months | Vaccine effectiveness defined at 6 months as the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick GERARDIN, MD | Contact | (262) 2 62 35 9435 | patrick.gerardin@chu-reunion.fr | |
| Florence LEFEBVRE D'HELLENCOURT | Contact | +262 262 75 34 71 | promotion.drci@chu-reunion.fr |
| Name | Affiliation | Role |
|---|---|---|
| Patrick GERARDIN, MD | CHU La Réunion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU La Réunion | Recruiting | Saint-Denis | France |
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| OTHER_GOV |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
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